The present invention relates to a vaginal device for therapeutic and diagnostic purposes, and more particularly to a resilient vaginal insert that exerts pressure upon the vaginal walls to diagnosis and treat various types of pelvic floor defects including urinary incontinence and prolapse and also to a system for the controlled and sustained delivery of pharmacological compounds for treatment of various diseases inside or outside the genital tract.
A significant number of women suffer from urinary stress Incontinence, primarily as a consequence of stresses to the musculature of the pelvic floor and ligaments supporting the bladder associated with childbirth. Surgical remedies and apparatus are known, such as that disclosed in U.S. Pat. No. 5,899,909 relating to a method and apparatus for placing a supportive surgical tape beneath the urethra. Surgery is contraindicated in some patients, however, due to intolerance to anesthesia, preference or other reasons. In addition to surgical treatments for incontinence, it has been known for many years that a suitably proportioned object placed within the vagina proximate to the urethra and/or bladder can be used to support, reposition and/or constrict the urethra and/or bladder to ameliorate incontinence. For example, an inflatable toroidal bladder (U.S. Pat. No. 5,007,894) and a five-sided plate with a U-shaped indentation for supporting/occluding the urethra (U.S. Pat. No. 4,139,006) have been proposed for vaginal insertion to treat incontinence. Certain of the proposed vaginal inserts are formed from resilient material, for example, a mushroom-shaped foam insert (U.S. Pat. No. 4,019,498), an arcuate member with a bladder neck cradle (U.S. Pat. No. 5,036,867) and a folding insert having legs that resiliently urge against the vaginal wall to exert pressure on he urethra (U.S. Pat. No. 5,618,256). 
The foregoing apparatus have varying degrees of effectiveness, ease of use, ease of removal, associated discomfort and hygienic impact. Accordingly, it remains an objective in the art to provide a vaginal insert addressing a variety of disorders, such as , urinary incontinence that is maximally effective, comfortable, easy to use and hygienic.
Further, there are numerous conditions of the genital tract, bladder or urinary tract, such as cancer, inflammation, infection or incontinence that may be treated by pharmaceutically active compounds. Many of these compounds are presently orally administered, however, this is a disadvantage in that systemic delivery is used to treat a condition or disease this is possibly more effectively treated by local applications. Also, may of the drugs used for the treatment of urge incontinence are anti-cholinergics with potent side effects. An intravesical administration would accomplish a high concentration of the drug locally without producing a high serum concentration.
Accordingly, it would be desirable to provide a sustained or controlled drug delivery device that is capable of delivery of the drug for an extended period of time, preferably one week or longer. It would be even more desirable to combine a drug delivery device with an apparatus for treating other clinical aliments.
The problems and disadvantages associated with the conventional techniques and devices utilized as vaginal pessaries are overcome by the present invention which includes a vaginal insert for, among other applications, relieving urinary incontinence. The insert has a generally cylindrical body dimensioned to allow insertion into the vagina. The body has at least one peripheral ring extending from the exterior surface of the body which displaces the vaginal wall, the tissue between the vaginal wall and the urethra to apply support to the vaginal walls and to the urethra assisting in preventing, for example, symptoms of urinary leakage and prolapse.
The vaginal insert is configured to deliver pharmaceutically active compounds such as Oxibutinine, Estradiol, Levonorgestrel and derivatives Lidocaine and similar substances, hormones, prostaglandin and other compunds.